Phenobarbital

Product NDC: 16571-675
11-digit product format: 165710675
Labeler code: 16571
Product ID: 16571-675_a84eee2c-e36f-478c-8793-b153799ea38b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenobarbital
Dosage form: LIQUID
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2020-09-01
Substance: PHENOBARBITAL
Active strength: 20 mg/5mL
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Phenobarbital
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENOBARBITAL	20 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YQE403BP4D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
702519	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fe874f8a-4b56-4d2b-abf5-8742e2633a3b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e3e67a66-d325-4d80-8f9d-059e736d7b00	Product name	1	20230912

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16571-675-16	Phenobarbital	473 mL in 1 BOTTLE	LIQUID	473		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-675	PHENOBARBITAL LIQUID [RISING PHARMA HOLDINGS, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20200916_fe874f8a-4b56-4d2b-abf5-8742e2633a3b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenobarbital	PHENOBARBITAL	Rising Pharma Holdings, Inc.	fe874f8a-4b56-4d2b-abf5-8742e2633a3b	2020-09-15	Warnings, Adverse reactions	Exact identifier ndc (product): 16571-675

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YQE403BP4D	PHENOBARBITAL	50-06-6	PHENOBARBITAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
702519	PHENobarbital 20 MG in 5 mL Oral Solution	PSN	d16f6911-f218-41ab-86c6-f3cceaf315e3	107
702519	phenobarbital 4 MG/ML Oral Solution	SCD	d16f6911-f218-41ab-86c6-f3cceaf315e3	107
702519	phenobarbital 20 MG per 5 ML Oral Solution	SY	d16f6911-f218-41ab-86c6-f3cceaf315e3	107
702519	phenobarbital 30 MG per 7.5 ML Oral Solution	SY	d16f6911-f218-41ab-86c6-f3cceaf315e3	107
702519	phenobarbital 60 MG per 15 ML Oral Solution	SY	d16f6911-f218-41ab-86c6-f3cceaf315e3	107
702519	PHENobarbital 20 MG in 5 mL Oral Solution	PSN	ee1fe3ac-7a2e-4133-90a2-1d8dc0552e74	100
702519	phenobarbital 4 MG/ML Oral Solution	SCD	ee1fe3ac-7a2e-4133-90a2-1d8dc0552e74	100
702519	phenobarbital 20 MG per 5 ML Oral Solution	SY	ee1fe3ac-7a2e-4133-90a2-1d8dc0552e74	100
702519	phenobarbital 30 MG per 7.5 ML Oral Solution	SY	ee1fe3ac-7a2e-4133-90a2-1d8dc0552e74	100
702519	phenobarbital 60 MG per 15 ML Oral Solution	SY	ee1fe3ac-7a2e-4133-90a2-1d8dc0552e74	100
702519	PHENobarbital 20 MG in 5 mL Oral Solution	PSN	fe874f8a-4b56-4d2b-abf5-8742e2633a3b	1
702519	PHENobarbital 20 MG in 5 mL Oral Solution	PSN	ac26cd10-8f66-4254-957c-87a909b576f8	1
702519	phenobarbital 4 MG/ML Oral Solution	SCD	ac26cd10-8f66-4254-957c-87a909b576f8	1
702519	phenobarbital 4 MG/ML Oral Solution	SCD	fe874f8a-4b56-4d2b-abf5-8742e2633a3b	1
702519	phenobarbital 20 MG per 5 ML Oral Solution	SY	fe874f8a-4b56-4d2b-abf5-8742e2633a3b	1
702519	phenobarbital 20 MG per 5 ML Oral Solution	SY	ac26cd10-8f66-4254-957c-87a909b576f8	1
702519	phenobarbital 30 MG per 7.5 ML Oral Solution	SY	fe874f8a-4b56-4d2b-abf5-8742e2633a3b	1
702519	phenobarbital 30 MG per 7.5 ML Oral Solution	SY	ac26cd10-8f66-4254-957c-87a909b576f8	1
702519	phenobarbital 60 MG per 15 ML Oral Solution	SY	fe874f8a-4b56-4d2b-abf5-8742e2633a3b	1
702519	phenobarbital 60 MG per 15 ML Oral Solution	SY	ac26cd10-8f66-4254-957c-87a909b576f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-675-16	16571067516	473 mL in 1 BOTTLE (16571-675-16)	473 ml	2020-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENOBARBITAL ORAL SOLUTION, USP CIV	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	107
PHENOBARBITAL ORAL SOLUTION, USP CIV	Bryant Ranch Prepack	2023-08-29	HUMAN PRESCRIPTION DRUG LABEL	100
PHENOBARBITAL ORAL SOLUTION, USP CIV	ATLANTIC BIOLOGICALS CORP	2023-04-18	Human Prescription Drug Label	1
PHENOBARBITAL ORAL SOLUTION, USP CIV	Rising Pharma Holdings, Inc. \| QUAGEN PHARMACEUTICALS LLC	2020-09-15	Human Prescription Drug Label	1